Carboplatin Injection — Class III drug recall D-1648-2012
Terminated recall by Hospira Inc., reported 2012-08-22, distributed nationwide. Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which t
| Recall number | D-1648-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2012-07-02 |
| Classified | 2012-08-16 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2017-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 77,542 vials |
| Reason classes | specification failure |
| NDC | 61703-0150, 61703-0150-05, 61703-0262, 61703-0262-05, 61703-0339, 61703-0339-18, 61703-0339-22, 61703-0339-50, 61703-0339-56, 61703-0360, 61703-0360-18, 61703-0360-50, 61703-0600, 61703-0600-05 |
| Lot numbers | Y031654AA, Y031654AB, Y041711AA, Y061711AA, Y061711AB |
| Expiration dates | 2012-12-20, 2013-02-20, 2013-04-20 |
Product
Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia
Reason for recall
Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1648-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.